BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2130360 · Received May 9, 2011

    Report

    Report Number
    2027969-2011-01017
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    March 7, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST RESULT WITH LAB RESULT PROVIDED BY END-USER AT THE TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 1.5, REF: 2.5, MEAN: 2.0, CONFIDENCE LIMITS: 1.3 - 2.7, RESULT: PASS. REPORTED RESULTS ARE WITHIN THE CONFIDENCE LIMITS FOR PASSING ACCURACY COMPARISON. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. IN-HOUSE TESTING HAS BEEN PERFORMED ON REPORTED LOT 243396 ON (B)(6) 2011. RESULTS AS FOLLOWS: INRATIO: 2.9, INRATIO: 2.9, INRATIO: 2.9, REFERENCE: 3.12, BIAS THRESHOLD: 2.12 - 4.12. THE MINIMUM TWO OUT OF THREE REPLICATES FOR THE DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. NO FURTHER INVESTIGATION IS NECESSARY. LIMITATIONS IN PACKAGE INSERT, "THIS TEST SHOULD NOT BE USED FOR PATIENTS ON HEPARIN THERAPY." IT MAY HAVE BEEN CONTRIBUTED TO UNEXPECTED RESULTS IN THIS COMPLAINT. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET ACCURACY CRITERIA. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4), NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: 1.5, LAB: 2.5. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 243396

    Patients

    Seq Age Sex Outcome Treatment
    1